Pegasis - Instructions For The Use Of Injections, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Pegasis

Pegasis: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Pegasys

ATX code: L03AB11

Active ingredient: peginterferon alfa-2a (peginterferon alfa-2a)

Producer: Roche Diagnostics (Germany), CATALENT BELGIUM (Belgium), F. Hoffmann-La Roche (Switzerland)

Description and photo update: 2019-23-08

Prices in pharmacies: from 5870 rubles.

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Pegasis is an antiviral immunomodulatory drug used in the treatment of chronic hepatitis.

Release form and composition

Pegasys is released in the form of a solution for subcutaneous administration: a clear liquid, from light yellow to colorless (0.5 or 0.6 ml each in syringe tubes with a needle (s), 1 syringe tube in a cardboard box; 0, 5 ml in syringe tubes with a built-in protected needle in the ProClick auto-injector, 1 auto-injector in a cardboard box; 1 ml each in vials (bottles), 1 or 4 bottles in a cardboard box).

The composition of 0.5 ml of solution includes:

• Active ingredient: peginterferon alpha-2a (40 kDa) - 0.135 or 0.18 mg;
• Additional components: benzyl alcohol - 5 mg; sodium chloride - 4 mg; sodium acetate trihydrate - 1.3085 mg; glacial acetic acid - 0.0231 mg; polysorbate 80 - 0.025 mg; 10% acetic acid - up to pH 6.0; 10% sodium acetate solution - up to pH 6.0; water for injection - up to 0.5 ml.

Pharmacological properties

Pharmacodynamics

Pegylated interferon alpha-2a (Pegasys) is a PEG (bis-monomethoxypolyethylene glycol) conjugate with interferon alpha-2a. Interferon alfa-2a is produced by recombinant DNA technology using a biosynthetic method and is a derivative of the cloned human leukocyte interferon gene, introduced and expressed in Escherichia coli cells.

As part of Pegasis, interferon alpha-2a is conjugated with bis-monomethoxy polyethylene glycol with the degree of substitution of one mole of polymer with one mole of protein.

The structure of PEG directly affects the clinical and pharmacological characteristics of Pegasis, in particular the degree of branching and the size of PEG with a molecular weight of 40 kDa determines the degree of absorption, distribution and excretion of peginterferon alfa-2a.

The activity of Pegasis should not be compared with other non-pegylated or pegylated proteins of the same therapeutic class.

Similar to interferon alpha-2a, Pegasys has antiviral and antiproliferative properties in vitro.

When responding to therapy with Pegasis at a dose of 0.18 mg, the decrease in the level of RNA of the virus in patients with chronic hepatitis C occurs in two phases. The first is observed 24–36 hours after the first administration of the drug, the second phase occurs in patients with a sustained virological response over the next 4–16 weeks.

In patients receiving combination therapy with ribavirin and pegylated interferon alfa-2a or interferon alfa, ribavirin does not significantly affect the kinetics of the virus during the first 4–6 weeks.

Pharmacokinetics

After a single injection of Pegasis at a dose of 0.18 mg, the drug is determined in the blood serum after 3–6 hours. After 24 hours, the serum peginterferon alfa-2a level reaches 80% of the maximum. Absorption is long-term, maximum plasma concentrations are observed 72–96 hours after drug administration. The absolute biological activity of peginterferon alfa-2a is similar to that of interferon alfa-2a and is 84%.

When the drug is administered intravenously, the volume of distribution in the equilibrium state is 6-14 liters. Peginterferon alfa-2a is found mainly in blood and extracellular fluid. According to the data of mass spectrometry and autoradioluminography studies carried out on rats in relation to the distribution of the substance in tissues, peginterferon alfa-2a is found in high concentrations in blood, bone marrow, kidneys and liver.

The specificity of the metabolism of peginterferon alfa-2a has not been fully studied, however, studies on rats have shown that the radiolabeled drug is excreted mainly by the kidneys.

The systemic clearance of peginterferon alfa-2a in humans is 100 times lower than that of interferon alfa-2a. The terminal elimination half-life (T _½) after intravenous administration of the drug to healthy volunteers was 60–80 hours (for ordinary interferon - 3-4 hours), after subcutaneous administration - about 160 hours (84–353 hours). Terminal T _½ after s / c administration may indicate not excretion, but duration of absorption of peginterferon alfa-2a.

In the case of the introduction of Pegasis 1 time per week, there is a dose-dependent increase in systemic exposure in healthy volunteers and patients with chronic hepatitis B or C (CHB or CHC). In patients with CHB or CHC, after 6–8 weeks of treatment with the use of the drug once a week, an equilibrium concentration is achieved, exceeding that after a single administration of peginterferon alfa-2a by 2–3 times. Subsequently (after 8 weeks of therapy), the accumulation of the substance does not occur. After 48 weeks of treatment, the ratio of the maximum and minimum concentration is 1.5–2. Serum concentrations of the drug are maintained for a week (168 hours) after administration.

Pharmacokinetics in special cases:

• impaired renal function: there is a slight decrease in clearance (CL / F) and an increase in the period T _½. With a creatinine clearance of 20-40 ml / min, the clearance of peginterferon alfa-2a decreases by 25% compared with patients without impaired renal function, with end-stage chronic renal failure in patients receiving hemodialysis - by 25-45%. When Pegasis is administered at a dose of 0.135 mg to patients with end-stage renal failure and the drug is administered at a dose of 0.18 mg to patients without renal impairment, the pharmacokinetics of peginterferon alfa-2a is similar;
• liver cirrhosis: pharmacokinetic parameters of the drug in healthy volunteers and patients with CHB or CHC are the same. With compensated cirrhosis, pharmacokinetics are similar to those in patients without cirrhosis (class A on the Child-Pugh scale);
• gender: after a single subcutaneous injection of the drug, the pharmacokinetic parameters of Pegasis in men and women are comparable;
• elderly age: in patients over 62 years of age, the absorption of peginterferon alfa-2a after a single subcutaneous administration at a dose of 0.18 mg slows down (the time to reach the maximum concentration is 115 hours versus 82 hours in healthy young volunteers), the AUC indicator (area under the curve "concentration - time ") is slightly increased (1663 vs. 1295 ng. h / mL), but the maximum concentration is not significantly changed. Given the data on the tolerability of the drug, its exposure and pharmacodynamic response, a reduction in the initial dose is not required in elderly patients;
• site of injection: the site of subcutaneous injection of Pegasis should be limited to the area of the anterior abdominal wall and thighs, because, according to the AUC, when injected into these sites, the degree of absorption of peginterferon alfa-2a is 20–30% higher. In studies with the introduction of the drug subcutaneously in the shoulder area, the concentration of the drug was lower.

Indications for use

• Chronic hepatitis C (CHC): in adults with positive HCV RNA, with compensated cirrhosis or without cirrhosis, incl. and with clinically stable HIV co-infection. In combination with ribavirin, Pegasis is prescribed to patients with CHC who have not previously received therapy, or to patients in whom previous monotherapy with interferon alfa (non-pegylated or pegylated) or combined therapy with ribavirin was ineffective. As monotherapy, Pegasis is prescribed for intolerance or contraindications to ribavirin;
• Chronic hepatitis B (CHB): HBeAg-positive and HBeAg-negative in adults with compensated liver damage and symptoms of viral replication, increased alanine aminotransferase activity, and histologically confirmed liver fibrosis and / or inflammation.

Contraindications

• Autoimmune hepatitis;
• Hepatic failure in severe course;
• Decompensated liver cirrhosis;
• Cirrhosis on the Child-Pugh scale - with a score of ≥6 in patients with HIV-CHC co-infection, provided that the increase in this indicator is not associated with indirect hyperbilirubinemia due to the use of drugs such as indinavir and atazanavir;
• Severe cardiovascular diseases in the stage of decompensation, incl. with poorly controlled unstable course during the previous 6 months;
• Age up to 3 years (due to benzyl alcohol, which is part of Pegasis);
• Pregnancy and breastfeeding period;
• Hypersensitivity to genetically engineered drugs obtained with E. coli, alpha interferons, polyethylene glycol or other Pegasis components.

When prescribing a combined treatment with ribavirin, the contraindications for the two drugs must be taken into account.

Instructions for the use of Pegasis: method and dosage

Pegasis injections should be injected subcutaneously into the thigh or anterior abdominal wall.

Therapy should be carried out under the supervision of an experienced physician.

When prescribing a combination treatment with ribavirin, the instructions for its use should also be considered.

With the standard dosing regimen, Pegasis is prescribed 1 time per week at a dose of 0.18 mg. Before the introduction, the solution should be inspected for color changes and the absence of impurities.

In the treatment of HBeAg-positive and HBeAg-negative CHB, the duration of the course of monotherapy is 48 weeks.

In CHC patients who have not previously received therapy, Pegasis is prescribed alone or in combination with oral ribavirin (with meals).

Recommended dosing regimen for rapid virological response (ribavirin dose (at body weight) / course duration; low viral load (NVH) - ≤ 800,000 IU / ml, high viral load (VVL) -> 800,000 IU / ml):

• Genotype 1: HBH - 1000 mg (<75 kg) or 1200 mg (≥75 kg) / 24 or 48 weeks; BBH - 1000 mg (<75 kg) or 1200 mg (≥75 kg) / 48 weeks;
• Genotype 2 or 3: HBH - 800 mg / 16 or 24 weeks; BBH - 800 mg / 24 weeks;
• Genotype 4: 1000 mg (<75 kg) or 1200 mg (≥75 kg) / 24 or 48 weeks.

Recommended dosing regimen without rapid virological response (dose of ribavirin (based on body weight) / course duration):

• Genotype 1 or 4: 1000 mg (<75 kg) or 1200 mg (≥75 kg) / 48 weeks
• Genotype 2 or 3: 800 mg / 24 weeks.

Regardless of the initial viral load, the duration of the course in patients with genotype 1, in whom HCV RNA is determined at 4 weeks of Pegasis use, should be 48 weeks.

A 24-week therapy may be associated with a greater likelihood of relapse than a 48-week therapy.

Clinical data in patients with genotypes 5 and 6 are limited, therefore, in this case, it is recommended to carry out combination therapy with ribavirin (1000/1200 mg) for 48 weeks.

The recommended duration of monotherapy is 48 weeks.

For patients who have previously received treatment, they are usually prescribed: Pegasis - once a week, 0.18 mg, ribavirin - 1000/1200 mg per day (body weight <75 / ≥75 kg).

If the virus is detected at 12 weeks of treatment, the drug is discontinued.

The recommended total course duration is 48 weeks. When deciding on the appointment of therapy for patients with genotype 1 who did not respond to previous treatment with pegylated interferon with ribavirin, the duration of the course is increased to 72 weeks.

In case of co-infection with HIV-HCV, Pegasis in a standard dose is used alone or simultaneously with ribavirin (800 mg). The duration of the course, regardless of genotype, is 48 weeks.

If a dose adjustment is necessary due to laboratory or clinical reactions of moderate to severe severity, it is usually sufficient to reduce the dose to 0.135 mg. However, in some cases, a dose reduction to 0.09 or 0.045 mg is required. After improvement of the condition, it is possible to increase the dose up to the standard one.

With a decrease in the number of neutrophils less than 750 cells / μl, a dose reduction is recommended. If the absolute neutrophil count (ANC) is less than 500 cells / μl, therapy should be interrupted until this indicator exceeds 1000 cells / μl. The use of Pegasis at a dose of 0.09 mg can be resumed under periodic monitoring of the number of neutrophils.

A dose reduction to 0.09 mg is shown when the platelet count is less than 50,000 cells / μl. If the number of platelets is less than 25,000 cells / μl, Pegasys is canceled. If anemia occurs during therapy, it is recommended:

• A decrease in the daily dose of ribavirin to 600 mg (200/400 mg in the morning and in the evening) is recommended in one of the following situations: a decrease in hemoglobin less than 10 g / dl, but more than 8.5 g / dl in patients without concomitant cardiovascular pathologies; a decrease in hemoglobin of 2 g / dl or more during any 4 weeks of treatment in the presence of stable cardiovascular disease. Increasing the dose of ribavirin to the initial dose is not recommended;
• Discontinuation of ribavirin is indicated in one of the following situations: a decrease in hemoglobin less than 8.5 g / dL in patients without concomitant cardiovascular pathologies; maintenance of hemoglobin at a level of less than 12 g / dL after 4 weeks, despite a dose reduction in the presence of stable cardiovascular disease. At the discretion of the doctor, after an improvement in performance, it is possible to resume taking ribavirin in a daily dose of 600 mg, followed by an increase to 800 mg. Increasing the dose to the standard dose (1000/1200 mg) is not recommended. In case of intolerance to ribavirin, further monotherapy with Pegasis is carried out.

During therapy, there is an increase in the activity of alanine aminotransferase (ALT) higher than the indicator before treatment, including patients with a virological response. With a progressive increase in ALT activity in comparison with the indicators before treatment, the dose is first reduced to 0.135 mg. If, despite this, the ALT indicator continues to increase or the treatment proceeds with an increase in the concentration of bilirubin or symptoms of hepatic decompensation, the therapy is canceled.

In patients with CHB, a transient increase in ALT activity is possible, in some cases exceeding the upper limit of the norm by 10 times, which may indicate immune clearance (therapy is not prescribed). After normalization of ALT activity, it is possible to resume the treatment course.

With compensated cirrhosis of the liver (on the Child-Pugh scale - class A), the use of Pegasis is considered safe and effective. In case of decompensated cirrhosis (on the Child-Pugh scale - class B / C or bleeding from esophageal varices), the safety profile of Pegasis has not been studied.

For patients with end-stage renal disease, Pegasis is prescribed at a dose of 0.135 mg. Such patients need careful monitoring of the condition and, in cases of side effects, further dose adjustment.

Elderly patients do not require dosage adjustment.

For children 3-18 years old, the safety profile of the drug has not been studied.

During therapy with Pegasis (monotherapy or combined use with ribavirin), cases of rejection of renal and hepatic transplants were recorded.

Side effects

In the treatment of CHC, the most common disorders are expressed, as a rule, in a mild or moderate degree, and no dose adjustment or discontinuation of therapy is required. The safety profile of Pegasis in the treatment of CHB is similar to that in CHC, however, with CHB, side effects develop with a much lower frequency, except for the incidence of fever.

Possible violations during the use of Pegasis (very often (≥1 / 10), often (≥1 / 100 and <1/10), infrequently (≥1 / 1000 and <1/100), rarely (≥1 / 10,000 and <1/1000), very rarely (<1/10 000)):

• Cardiovascular system: often - palpitations, tachycardia, peripheral edema; infrequently - arterial hypertension; rarely - cardiomyopathy, congestive heart failure, angina pectoris, myocardial infarction, arrhythmia, cerebral hemorrhage, supraventricular tachycardia, atrial fibrillation, pericarditis, vasculitis;
• Musculoskeletal system: very often - arthralgia, myalgia; often - pain (in bones, back, neck), muscle weakness, arthritis, muscle cramps, musculoskeletal pain; rarely - myositis;
• Respiratory system: very often - dyspnea, cough; often - nosebleeds, dyspnea during exercise, nasopharyngitis, sore throat, nasal congestion, sinus swelling, inflammation of the nasal mucosa; infrequently - wheezing; rarely - pulmonary embolism, interstitial pneumonitis;
• Hepatobiliary system: infrequently - functional liver disorders; rarely - cholangitis, hepatic failure, fatty degeneration of the liver;
• Digestive system: very often - nausea, diarrhea, abdominal pain; often - bleeding gums, vomiting, dysphagia, dyspepsia, ulceration of the oral mucosa, glossitis, flatulence, stomatitis, dryness of the oral mucosa; infrequently - gastrointestinal bleeding; rarely - pancreatitis, peptic ulcer;
• Immune system: infrequently - Benier-Beck-Schaumann disease, thyroiditis; rarely - systemic lupus erythematosus, anaphylaxis, rheumatoid arthritis; very rarely - thrombotic or idiopathic thrombocytopenic purpura, angioedema;
• Urinary system: rarely - renal failure;
• Lymphatic system and blood: often - anemia, thrombocytopenia, lymphadenopathy; rarely - panhemocytopenia; very rarely - aplastic anemia;
• Reproductive system: often - impotence;
• Endocrine system: often - hyperthyroidism, hypothyroidism; infrequently - diabetes mellitus; rarely, diabetic ketoacidosis;
• Nervous system: very often - dizziness, headache, impaired concentration; often - syncope, memory impairment, weakness, nightmares, migraine, hyperesthesia, hypesthesia, paresthesia, impaired taste, tremor, drowsiness; infrequently - peripheral neuropathy; rarely - convulsions, coma, neuritis of the facial nerve;
• Infections: often - herpes simplex, bronchitis, upper respiratory tract infections, candidiasis of the oral mucosa, infections of fungal and bacterial etiology; infrequently - skin infections, pneumonia; rarely - otitis externa, endocarditis;
• Neoplasms (benign and malignant): infrequently - liver neoplasm;
• Metabolism: very often - anorexia; infrequently - dehydration;
• Psyche: very often - anxiety, depression, insomnia; often - mood changes, decreased libido, emotional disorders, nervousness, aggressiveness; infrequently - suicidal thoughts, hallucinations; rarely - mental disorders, suicide;
• Vision: often - xerophthalmia, pain in the eyeball, blurred vision, eye diseases of inflammatory etiology; infrequently - retinal hemorrhage; rarely - retinal vascular lesions, neuritis and edema of the optic nipple, retinopathy, corneal ulcer; very rarely - loss of vision;
• Hearing: often - ear pain, vertigo; infrequently - hearing loss;
• Skin and its appendages: very often - itching, alopecia, dermatitis, dry skin; often - photosensitivity reactions, increased sweating, rash, psoriasis, eczema, urticaria, skin reactions, night sweats; very rarely - Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme;
• The body as a whole: very often - fever, irritability, chills, pain, asthenia, weakness, reactions at the injection site; often - lethargy, weight loss, flu-like syndrome, chest pain, malaise, thirst, hot flashes.

As a result of post-marketing observations, the following side effects were recorded:

• Hematopoietic system: very rarely, when used with ribavirin, partial red cell aplasia of the bone marrow;
• Nervous system: with unknown frequency - ischemic stroke;
• Musculoskeletal system: with unknown frequency - rhabdomyolysis;
• Psyche: very rarely when used with ribavirin - homicidal ideas;
• Organ of vision: with unknown frequency - retinal detachment;
• Other: rejection of renal and hepatic transplants.

During the use of Pegasis, such changes in laboratory test data may be observed:

• Laboratory indicators: increased activity of alanine aminotransferase, hypertriglyceridemia, hyperbilirubinemia, electrolyte disturbances (hypocalcemia, hypokalemia, hypophosphatemia), hyper- and hypoglycemia;
• Hematological indicators: a decrease in hematological indicators (in the form of leukopenia, neutropenia, lymphopenia, thrombocytopenia and a decrease in hemoglobin). Improvement is seen with dose changes. In 1-2 months after stopping treatment, the indicators return to normal;
• Antibodies to interferon: the formation of neutralizing antibodies to interferon (more often - with CHB);
• Laboratory indicators of thyroid function: clinically significant changes that require medical intervention;
• Laboratory indicators for co-infection with HIV-CHC: phenomena of hematological toxicity (thrombocytopenia, neutropenia, anemia). Typically adjusted by dose variation and use of growth factors. Premature withdrawal of treatment is rarely required.

Overdose

There are known cases of overdose with daily administration of Pegasis (without observing weekly intervals) for 2 consecutive days and for 7 consecutive days (weekly dose - 1.26 mg). No unusual or serious side effects were reported.

In clinical trials, the drug was administered to patients with kidney cancer and chronic myeloid leukemia at weekly doses of up to 0.54 and 0.63 mg. The following signs of toxicity were noted, which limited the further use of Pegasis in the same doses: weakness, thrombocytopenia, neutropenia, increased activity of liver enzymes. However, it is worth noting that these symptoms are also possible with conventional interferons.

There is no specific antidote for peginterferon alpha-2a. Hemodialysis and peritoneal dialysis are ineffective.

special instructions

In some cases, during therapy and for six months after its completion, there are severe side effects from the central nervous system in the form of depression, suicidal mood and suicidal attempts. In this regard, regardless of age, patients need careful monitoring of their condition. If dangerous symptoms appear, treatment cancellation is possible.

It should be borne in mind that the progression of fibrosis in patients with a normal level of ALT activity is usually slower than with an increased level of ALT activity.

Before starting the use of Pegasis, all patients are recommended to undergo standard general clinical and biochemical blood tests. The course is prescribed for the following indicators: absolute neutrophil count ≥1500 cells / μl; platelet count ≥90,000 cells / μl; compensated thyroid function (TSH and T4 should be within normal limits); the number of CD4 ⁺ lymphocytes is ≥200 cells / μl or CD4 ⁺ is in the range of ≥100- <200 cells / μl, in patients with HIV-CHC co-infection - HIV-1 RNA is <5000 copies / ml. If hemoglobin is less than 12 g / dL, Pegasys (alone or in combination with ribavirin) should be used with caution.

After the start of the treatment course, the biochemical blood test must be repeated after 4 weeks, the general clinical one - after 2 and 4 weeks. Also during therapy, periodic laboratory tests are indicated.

According to the instructions, Pegasis is prescribed with caution in combination with other myelotoxic agents.

During the use of the drug, thyroid dysfunction or deterioration of preexisting thyroid diseases may occur. If thyroid-stimulating hormone (TSH) levels can be maintained with medication, treatment is continued.

If hypoglycemia, hyperglycemia or diabetes mellitus develops during the use of Pegasis, therapy should be canceled.

Patients with cardiovascular pathologies are advised to have an ECG before starting treatment. If the condition worsens, therapy is interrupted. Also, Pegasis is canceled in the event of liver failure, serious immediate hypersensitivity reactions, respiratory dysfunctions, or persistent (persistent) infiltrates or infiltrates of unknown origin.

Patients with symptoms similar to those of autoimmune diseases should undergo a thorough examination before prescribing a course.

Fever during the use of Pegasis may be associated with a flu-like syndrome that often develops with interferon therapy, but other causes, including serious infections of fungal, viral and bacterial etiology, must be excluded, especially in patients with neutropenia.

All patients need to undergo an ophthalmological examination to detect fundus pathology before prescribing a treatment course. In case of complaints of deteriorating visual acuity or narrowing of its fields, a complete ophthalmological examination is required, in the presence of concomitant diseases of the organ of vision during therapy, additional examinations are carried out.

In case of exacerbation or induction of sarcoidosis and psoriasis, Pegasis is prescribed with caution, and in case of exacerbation or signs of the development of these diseases, therapy can be canceled.

Due to the high likelihood of anemia, the combined use of ribavirin and zidovudine is not recommended.

Patients with co-infection should be closely monitored for signs of hepatic decompensation (including encephalopathy, ascites, variceal bleeding).

Influence on the ability to drive vehicles and complex mechanisms

With the development of weakness, drowsiness, dizziness and confusion, it is recommended to refuse to drive vehicles for the period of Pegasis use.

Application during pregnancy and lactation

Effect of peginterferon alfa-2a on the fetus: category C.

The effect of Pegasis on fertility in women has not been studied. In animals receiving peginterferon alpha-2a (like other alpha interferons), the menstrual cycle lengthened (normalized after drug withdrawal), decreased or later reached maximum concentrations of progesterone and 17β-estradiol.

The effect of Pegasis on male fertility has not been studied either. In animals receiving interferon alfa-2a for 5 months, no adverse effects were noted.

Studies on the development of teratogenic effects have not been conducted. The use of interferon alpha-2a in rhesus monkeys significantly increased the number of spontaneous abortions. In offspring born at term, no teratogenic effects were noted.

Pegasis is contraindicated during pregnancy. Women of childbearing age should use reliable contraceptives during drug treatment.

It is not known whether peginterferon alfa-2a and its components penetrate into breast milk. For safety reasons, Pegasys is not recommended for use during lactation. If treatment is necessary, it is recommended to stop breastfeeding.

Effect on the fetus of combination therapy of peginterferon alfa-2a with ribavirin: category X.

Animal studies have shown a pronounced teratogenic effect of ribavirin and its ability to cause fetal death. Ribavirin is contraindicated in pregnant women and men whose partners are pregnant. It can be prescribed only after receiving a negative pregnancy test, carried out immediately before starting therapy. Women of childbearing age and men whose partners are of reproductive age should be informed about the teratogenic effects of ribavirin and the need to use reliable contraceptive methods (at least two) during treatment and for 6 months after it ends.

Pediatric use

The efficacy and safety of peginterferon alfa-2a in pediatric and adolescent patients (under 18 years of age) have not been established. The solution contains benzyl alcohol, which in young children can cause neurological and other complications, sometimes leading to death. In this regard, Pegasis is strictly contraindicated in children under 3 years of age.

With impaired renal function

Patients with end-stage renal disease undergoing hemodialysis are recommended to reduce the dose of Pegasis to 0.135 mg.

Regardless of the severity of renal failure and the initial dose of the drug, patients should be under close medical supervision. In the event of side effects, the dose of Pegasis should be reduced.

For violations of liver function

With compensated cirrhosis of the liver (class A according to the Child-Pugh classification), there is no need to adjust the dose of Pegasis.

The use of Pegasis in decompensated cirrhosis of the liver (class B / C according to Child-Pugh or bleeding from esophageal varices) has not been studied, and therefore, the drug is contraindicated in patients with this pathology.

Severe liver failure is a contraindication to prescribing a drug.

With a clinically significant or progressive increase in the level of alanine aminotransferase (ALT) during treatment with the drug, the dose of peginterferon alfa-2a is reduced to 0.135 mg. If, despite the dose reduction, the enzyme activity continues to increase, or there is an increase in the level of direct bilirubin, or signs of hepatic decompensation appear, Pegasis injections are canceled.

In patients with CHB, a transient increase in ALT levels is possible, which in some cases exceeds the upper limit of the norm by 10 times and may indicate immune clearance. In this regard, the use of Pegasis requires careful and frequent monitoring of the level of this enzyme. In the case of a decrease in the dose of the drug or its temporary cancellation, therapy can be resumed after the normalization of ALT activity.

In all cases, it is recommended to monitor liver function more frequently.

The safety and efficacy of Pegasis as monotherapy or in combination with ribavirin in patients after liver transplantation have not been studied.

Use in the elderly

Elderly patients do not need to adjust the recommended dose (0.18 mg once a week).

Drug interactions

With the combined use of Pegasis or a combination of Pegasis with ribavirin with certain drugs / substances, the following effects may occur:

• Theophylline: an increase in its AUC (control is necessary, especially after 4 weeks of Pegasis use);
• Methadone: an increase in the average levels of its metabolites (careful monitoring of symptoms of intoxication is required), at high doses - an increase in the likelihood of prolongation of the QTc interval;
• Didanosine and its active metabolite (interaction with ribavirin): development of pancreatitis, fatal liver failure, peripheral neuropathy, symptomatic hyperlactatemia / lactic acidosis;
• Zidovudine (interaction with ribavirin): worsening anemia; simultaneous use is not recommended, especially if there is a history of data on anemia caused by zidovudine;
• Telbivudine (in a daily dose of 600 mg): an increase in the likelihood of developing peripheral neuropathy;
• Azathioprine: enhancement of its myelotoxic action; simultaneous administration is possible after the ratio of benefit to risk, while careful monitoring of the blood composition for the development of myelotoxicity is necessary, in case of its development, combination therapy is canceled.

Due to the lack of data, Pegasys cannot be mixed with other drugs.

Analogs

Pegasis analogs are: Pegferon Peg, Alfaferon, Blastopheron, Genferon, Viferon, Peg-Interferon, Rebif, Silatron, PegIntron, Algeron.

Terms and conditions of storage

Store in a dark place, out of reach of children, at a temperature of 2-8 ° C, do not freeze. Transportation is carried out under the same conditions.

The shelf life of the drug in the ProClick auto-injector is 2 years, syringe tubes - 3 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Pegasis

On specialized medical sites and forums, you can find different reviews about Pegasis. However, in the overwhelming majority of reports, patients describe, if not a cure, then a significant improvement.

Negative opinions about Pegasys are usually due to the development of side effects, including nausea, weight loss, irritability. Some patients complain about the lack of effect of therapy. Doctors also note that this may depend, among other things, on the individual characteristics of the patient, the genotype of the virus and the presence of coinfection.

The price of Pegasys in pharmacies

The price of Pegasys in the form of a solution for subcutaneous administration with a dosage of 0.18 mg / 0.5 ml averages 5500–6350 rubles. for 1 syringe tube.

Pegasis: prices in online pharmacies

Drug name Price Pharmacy

Pegasis 0.36 mg / ml solution for subcutaneous administration 0.5 ml 1 pc. RUB 5870 Buy

Pegasis 180 μg / 0.5 ml solution for subcutaneous administration 0.5 ml 1 pc. RUB 6754 Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!